Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.

Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.

Breast Cancer

Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP

Crofelemer

Lombardi Comprehensive Cancer Center

MedStar Franklin Square Cancer Center at Loch Raven Campus

Harry and Jeanette Weinberg Cancer Institute

John Theurer Cancer Center at Hackensack Univ

Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients

Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients Receiving Trastuzumab, Pertuzumab, and Docetaxel or Paclitaxel With or Without Carboplatin: HALT-D

Incidence of all grade diarrhea lasting 2 or more consecutive days during cycles 1 and 2 of chemotherapy

Incidence of diarrhea of any grade, as measured by CTCAE v4.0, by cycle and by stratum

Incidence of diarrhea of grade 3-4, as measured by CTCAE v4.0, by cycle and by stratum

Time to onset of first episode of diarrhea of any grade, overall and by stratum

Duration (days) of any grade diarrhea, defined from day 1 to day 21, by cycle in which the episode started and by stratum

Duration (days) of grade 3-4 diarrhea, defined from day 1 to day 21, by cycle in which the episode started and by stratum

Use of anti-diarrheal medications (other than study drug), by cycle and grade

Quantitative FACIT-D total score, collected day 1 of each cycle and at the time of study completion, by cycle and by stratum

Quantitative FACIT-D diarrhea subset (DS) score, by cycle and by stratum

Frequency table of stool consistency, as measured by the Bristol Stool scale, by cycle stratum between treatment groups

No plan to make individual participant data available

Paula R. Pohlmann, MD, PhD

Medical Oncologist

Georgetown University

Medstar Health Research Institute

Genentech, Inc.

Napo Pharmaceuticals, Inc.

Bone Metastasis

Pain

chemoradiation

Rabin Medical Center, Beilinson Campus

Chemoradiation for Bone Metastasis

Chemoradiation With Capecitabine for Palliation of Pain From Bone Metastasis

Patients were asked to score their pain on a scale of 0 (no pain) to 10 (worst possible pain) before treatment and at 1, 2, 4, 8 and 12 weeks after treatment initiation.

Consumption of analgesics was evaluated by the physician using the 5-point WHO score, as follows: level 0, no analgesics required; level 1, non-narcotic analgesics required occasionally; level 2, non-narcotic analgesics required regularly; level 3, narcotic analgesics required occasionally; level 4, narcotic analgesics required regularly

codeine/diarrhea

Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients

Chemoradiation for Bone Metastasis

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